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Device Explorer · FDA GUDID · GMDN 38565

Gastrostomy button

A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.

US‑registered devices2,437in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription70%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Applied Medical Technology, Inc.1,32754%
Avanos Medical, Inc.83934%
Corpak Medsystems, Inc.994%
Degania Silicone Ltd894%
Owens & Minor Distribution, Inc.773%
Fidmi Medical Ltd50%
Cardinal Health, Inc.10%

Top labelers

CompanyDevicesShare
Applied Medical Technology, Inc.1,32754%
Avanos Medical, Inc.83934%
Corpak Medsystems, Inc.994%
Degania Silicone Ltd894%
Owens & Minor Distribution, Inc.773%
Fidmi Medical Ltd50%
Cardinal Health, Inc.10%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MedlineLow Profile Enteral Feeding Device KitMINI Balloon ButtonMiniONE Balloon ButtonMiniONE Capsule Non-Balloon ButtonMiniONE Non-Balloon ButtonNon-Balloon Removal ToolAMT Mini™ Balloon ButtonMini ONE® Balloon ButtonAMT ButtonMini ONE® Capsule Non-Balloon ButtonMini ONE® Non-Balloon ButtonAVANOSKangarooHalyardCORFLO cuBBy LPGD

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KNTTubes, Gastrointestinal (And Accessories)1,342
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)760
KNTTubes, gastrointestinal (and accessories)297
PSHPercutaneous Replacement Gastrostomy Tube Kit88
KGCTUBE, GASTRO-ENTEROSTOMY14
KGCTube, Gastro-Enterostomy5

GMDN & GCC registration

  • GMDN code 38565 · implantable
  • Single‑use 100% · sterile 99% · Rx‑only 70% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Catheter Gauge (French) · 1,997Length (Centimeter) · 1,451

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many gastrostomy button products are registered in the US?

2,437 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gastrostomy button", from 7 companies. The largest labeler is Applied Medical Technology, Inc. with 54% of records.

Which FDA product codes apply?

KNT (Tubes, Gastrointestinal (And Accessories)), KNT (TUBES, GASTROINTESTINAL (AND ACCESSORIES)), KNT (Tubes, gastrointestinal (and accessories)), PSH (Percutaneous Replacement Gastrostomy Tube Kit)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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